A review of the safety of antibody therapy in severe eosinophilic asthma.

Abstract

Introduction: Severe eosinophilic asthma (SEA) is characterized by persistent type 2 airway inflammation and frequent exacerbations despite maximal conventional therapy. The advent of biologics targeting interleukin-5, its receptor, and upstream mediators has markedly changed disease management, offering new therapeutic opportunities for patients with uncontrolled disease.

Areas covered: This review evaluates the safety profiles of currently approved biologics for SEA, including mepolizumab, reslizumab, benralizumab, dupilumab, and tezepelumab. Evidence was synthesized from randomized controlled trials, open-label extension studies, real-world data, and pharmacovigilance reports. Mepolizumab demonstrates consistent safety with mainly mild adverse events, while reslizumab is effective but rarely associated with myalgia, creatine phosphokinase elevations, and anaphylaxis. Benralizumab shows excellent tolerability, with a low incidence of injection reactions and no excess of serious adverse events. Dupilumab is well tolerated, though blood eosinophilia and conjunctivitis may occur. Tezepelumab approval was supported by favorable safety signals, with mild infections and headache as the most frequent events.

Expert opinion: Current evidence indicates that biologic therapies for SEA are safe and well tolerated, with serious adverse events being rare. Nevertheless, long-term and comparative safety data remain limited, and ongoing pharmacovigilance and post-marketing surveillance are essential to fully define risk profiles.